Completion of the Phase 1 EPI-7386 combination
study with Xtandi® (enzalutamide)
expected in the third calendar quarter of 2023 followed by
initiation of the randomized Phase 2 part of the study
Entered into clinical trial support agreement
with Janssen to supply Erleada® (apalutamide) and
Zytiga® (abiraterone acetate) for an ESSA-sponsored
Phase 1 study of EPI-7386 combination therapies; enrollment
expected to begin 2H2023
Phase 1b
EPI-7386 monotherapy expansion study in mCRPC patients
ongoing
SAN
FRANCISCO, California and VANCOUVER, Canada, Aug. 8, 2023
/CNW/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX),
a clinical-stage pharmaceutical company focused on developing novel
therapies for the treatment of prostate cancer, today provided a
corporate update and reported financial results for the fiscal
third quarter ended June 30, 2023.
All references to "$" in this release refer to United States dollars, unless otherwise
indicated.
"Over the past months we have ramped up preparations to initiate
the randomized Phase 2 combination study of EPI-7386 and Astellas
and Pfizer's antiandrogen Xtandi® (enzalutamide), and we
expect to complete the Phase 1 part of the study in the coming
quarter," stated David Parkinson,
MD, President and CEO of ESSA. "In the past quarter, we finalized
our clinical collaboration with Janssen to evaluate EPI-7386 in
combination with Janssen's antiandrogens
Erleada® (apalutamide) and
Zytiga® (abiraterone acetate) in two Phase 1
cohorts, building on initial Phase 1 clinical data demonstrating
promising prostate-specific antigen ("PSA") declines following
combination treatment. ESSA is in a strong cash position as we
advance our EPI-7386 studies, with our cash runway expected to fund
operations and programs through 2025."
Clinical and Corporate
Highlights for the Third Quarter Ended June
30, 2023
EPI-7386 Clinical Collaborations
- The Company is preparing to initiate the open-label, randomized
Phase 2 study of EPI-7386 and Astellas and Pfizer's antiandrogen
Xtandi® (enzalutamide) in patients with metastatic
castration-resistant prostate cancer ("mCRPC") naïve to
second-generation antiandrogens. The Phase 2 study will assess the
anti-tumor activity of EPI-7386 in combination with enzalutamide at
the recommended Phase 2 doses versus single agent enzalutamide at
the standard-of-care dose. The study is expected to enroll
approximately 120 patients. The Company expects to complete the
Phase 1 part of the study and establish the recommended Phase 2
combination doses (for both EPI-7386 and enzalutamide when used in
combination) in the third calendar quarter of 2023, followed by
initiation of the Phase 2 part of the study.
- In April 2023, the Company
entered into a clinical trial support agreement with Janssen
Research & Development, LLC ("Janssen") under which Janssen
will supply apalutamide and abiraterone acetate for a Phase 1
clinical study sponsored and conducted by ESSA evaluating EPI-7386
combination therapies in two cohorts. The two cohorts will be
evaluated as additional cohorts in the Company's ongoing Phase 1
study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort
1 will assess EPI-7386 in combination with abiraterone acetate plus
prednisone in patients with mCRPC and high-risk metastatic
castration-sensitive prostate cancer. Cohort 2 is a Window of
Opportunity study in which patients with non-metastatic
castration-resistant prostate cancer ("nmCRPC") will receive up to
12 weeks of single agent EPI-7386 before adding standard-of-care
apalutamide. ESSA will retain all rights to EPI-7386. The Company
expects enrollment to begin in the second half of calendar
2023.
EPI-7386 Monotherapy
- The Phase 1b EPI-7386 monotherapy
dose expansion study is ongoing and is evaluating two
doses/schedules of single agent EPI-7386 in mCRPC patients with
less than three prior lines of therapy, no visceral disease and no
prior chemotherapy who have progressed on at least one
second-generation antiandrogen. The Company is also enrolling
nmCRPC patients in the Window of Opportunity cohort of the study,
in which patients will receive 12 weeks of EPI-7386 monotherapy
treatment before starting standard-of-care therapy.
Corporate Updates
- In June 2023, the Company
announced the appointment of Lauren
Merendino, M.B.A., to its Board of Directors. Ms. Merendino
is a leading biopharmaceutical executive who brings over 25 years
of commercial experience spanning 20+ disease states, including 15
years of leadership for oncology-specific portfolios.
Summary Financial Results
- Net Loss. ESSA recorded a comprehensive loss of
$7.3 million for the third quarter
ended June 30, 2023, compared to a
comprehensive loss of $8.8 million
for the third quarter ended June 30,
2022. For the third quarter ended June 30, 2023, this included non-cash share-based
payments of $1.2 million compared to
$1.6 million for the prior year,
recognized for stock options granted and vesting. The decrease in
the third quarter was primarily attributed to decreases in research
and development expenditures and general and administration
expenditures in addition to an increase of $1.2 in interest and other income.
- Research and Development ("R&D") expenditures.
R&D expenditures for the third quarter ended June 30, 2023 were $6.3
million compared to $6.4
million for the third quarter ended June 30, 2022 and include non-cash costs related
to share-based payments ($599,621 for
the third quarter ended 2023 compared to $872,531 for the third quarter ended 2022). The
decrease in R&D expenditures for the year ended June 30, 2023 is the result of decreased non-cash
share-based payments, legal patents and license fees and
manufacturing costs related to the Phase 1 clinical trial of
EPI-7386.
- General and administration ("G&A") expenditures.
G&A expenditures for the third quarter ended June 30, 2023 were $2.6
million compared to $2.9
million for the third quarter ended June 30, 2022 and include non-cash costs related
to share-based payments of $561,452
for the third quarter ended 2023 compared to $718,469 for the third quarter ended 2022. The
decrease in the third quarter is the result of decreased non-cash
share-based payments, salaries and benefits and consulting and
subcontractor fees.
Liquidity and Outstanding Share
Capital
At June 30, 2023, the Company had
available cash reserves and short-term investments of $152.5 million reflecting the gross proceeds
of the February 2021 financing of
approximately $150.0 million, less
operating expenses in the intervening period. The Company's
cash position is expected to be sufficient to fund current and
planned operations through 2025.
As of June 30, 2023, the Company
had 44,092,374 common shares issued and outstanding.
In addition, as of June 30, 2023
there were 2,927,477 common shares issuable upon the exercise of
warrants and broker warrants. This includes 2,920,000 prefunded
warrants at an exercise price of $0.0001, and 7,477 warrants at a weighted average
exercise price of $42.80. There were
8,150,274 common shares issuable upon the exercise of outstanding
stock options at a weighted-average exercise price of $5.05 per common share.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on
developing novel and proprietary therapies for the treatment of
patients with prostate cancer. For more information, please visit
www.essapharma.com and follow us on Twitter under
@ESSAPharma.
Forward-Looking Statement
Disclaimer
This release contains certain information which, as presented,
constitutes "forward-looking information" within the meaning of the
Private Securities Litigation Reform Act of 1995 and/or applicable
Canadian securities laws. Forward-looking information involves
statements that relate to future events and often addresses
expected future business and financial performance, containing
words such as "anticipate", "believe", "plan", "estimate",
"expect", and "intend", statements that an action or event "may",
"might", "could", "should", or "will" be taken or occur, or other
similar expressions and includes, but is not limited to, statements
regarding the completion of the Phase 1 combination study with
enzalutamide and initiation of the randomized Phase 2 part of the
study, enrollment in the monotherapy and combination
studies, the assessment of anti-tumor activity in the Phase 2
combination study, the clinical trial support agreement, the supply
of apalutamide and abiraterone acetate, the rights to EPI-7386, the
testing of new antiandrogen combinations with EPI-7386, the
treatments under Cohort 1 and Cohort 2 of the Phase 1 clinical
trial, the Phase 1b dose expansion
study and the Window of Opportunity Study, and the Company's
expected cash runway into 2025.
Forward-looking statements and information are subject to
various known and unknown risks and uncertainties, many of which
are beyond the ability of ESSA to control or predict, and which may
cause ESSA's actual results, performance or achievements to be
materially different from those expressed or implied thereby. Such
statements reflect ESSA's current views with respect to future
events, are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while
considered reasonable by ESSA as of the date of such statements,
are inherently subject to significant medical, scientific,
business, economic, competitive, political and social uncertainties
and contingencies. In making forward looking statements, ESSA may
make various material assumptions, including but not limited to (i)
the accuracy of ESSA's financial projections; (ii) obtaining
positive results of clinical trials; (iii) obtaining necessary
regulatory approvals; and (iv) general business, market and
economic conditions.
Forward-looking information is developed based on assumptions
about such risks, uncertainties and other factors set out herein
and in ESSA's Annual Report on Form 10-K dated December 13, 2022 under the heading "Risk
Factors", a copy of which is available on ESSA's profile on EDGAR
at www.sec.gov.com and on the SEDAR website at www.sedar.com,
and as otherwise disclosed from time to time on ESSA's EDGAR and
SEDAR profiles. Forward-looking statements are made based on
management's beliefs, estimates and opinions on the date that
statements are made and ESSA undertakes no obligation to update
forward-looking statements if these beliefs, estimates and opinions
or other circumstances should change, except as may be required by
applicable United States and
Canadian securities laws. Readers are cautioned against attributing
undue certainty to forward-looking statements.
ESSA PHARMA INC.
CONDENSED CONSOLIDATED INTERIM
BALANCE SHEETS
(Unaudited)
Amounts in thousands of United States dollars
|
|
|
|
|
June 30,
2023
|
|
September 30,
2022
|
|
|
|
|
Cash and cash
equivalents
|
$
38,467
|
|
$
57,076
|
Prepaids and other
assets
|
115,183
|
|
112,429
|
|
|
|
|
Total assets
|
$
153,650
|
|
$
169,505
|
|
|
|
|
Current
liabilities
|
3,407
|
|
2,310
|
Long-term
debt
|
—
|
|
76
|
Shareholders'
equity
|
150,243
|
|
167,118
|
|
|
|
|
Total liabilities and
shareholders' equity
|
$
153,650
|
|
$
169,505
|
ESSA PHARMA INC.
CONDENSED CONSOLIDATED INTERIM
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Amounts in thousands of United States dollars, except share and per
share data
|
|
|
|
|
|
|
|
|
Three months
ended June 30, 2023
|
|
Three months
ended June 30, 2022
|
|
Nine months
ended June 30, 2023
|
|
Nine months
ended June 30, 2022
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research and development
|
$
6,271
|
|
$
6,395
|
|
$
16,096
|
|
$
20,064
|
Financing costs
|
2
|
|
3
|
|
6
|
|
11
|
General and administration
|
2,639
|
|
2,896
|
|
8,889
|
|
9,775
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
(8,912)
|
|
(9,294)
|
|
(24,991)
|
|
(29,850)
|
|
|
|
|
|
|
|
|
Gain on derivative
liability
|
—
|
|
2
|
|
—
|
|
20
|
Interest and
other items
|
1,613
|
|
419
|
|
3,892
|
|
1,005
|
|
|
|
|
|
|
|
|
Net loss before
taxes
|
(7,299)
|
|
(8,873)
|
|
(21,099)
|
|
(28,825)
|
Income tax expense
(recovery)
|
—
|
|
46
|
|
(2)
|
|
46
|
|
|
|
|
|
|
|
|
Net loss for the
period
|
$
(7,299)
|
|
$
(8,827)
|
|
$
(21,101)
|
|
$
(28,779)
|
|
|
|
|
|
|
|
|
OTHER
COMPREHENSIVE
LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on short-
term investments
|
43
|
|
(3)
|
|
13
|
|
(52)
|
|
|
|
|
|
|
|
|
Loss and comprehensive
loss for
the period
|
$
(7,256)
|
|
$
(8,830)
|
|
$
(21,088)
|
|
$
(28,831)
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per
common share
|
$
(0.17)
|
|
$
(0.20)
|
|
$
(0.48)
|
|
$
(0.65)
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares
outstanding
|
44,092,374
|
|
44,059,700
|
|
44,085,941
|
|
44,026,502
|
View original
content:https://www.prnewswire.com/news-releases/essa-pharma-provides-corporate-update-and-reports-financial-results-for-fiscal-third-quarter-ended-june-30-2023-301895056.html
SOURCE ESSA Pharma Inc